A Single-dose, Randomised, Crossover, Placebo-controlled Study Assessing Two Fixed-dose Combinations of Inhaled Long-acting Beta-agonist and Corticosteroid

Asthma Clinical Trial

Official title:

A Single-dose, Randomised, Crossover, Placebo-controlled, Double-dummy, Pharmacodynamic Clinical Trial Assessing Two Fixed Dose Combinations of Long-acting Beta-agonist (LABA) and Inhaled Corticosteroid (ICS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094274
• Other study ID #: M-40468-10
• Secondary ID: 2013-002939-25
• Status: Completed
• Phase: Phase 1
• First received: March 20, 2014
• Last updated: May 21, 2014
• Start date: November 2013
• Est. completion date: May 2014

Study information

• Verified date: March 2014
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the the ability of a single dose of LAS40468 administered via Genuair® and a single dose of salmeterol/fluticasone propionate (Seretide®) administered via Accuhaler to produce bronchodilation (opening of the airways) and the safety and tolerability of the treatments

Description:

This is a Phase 1, randomised, double-blind, double-dummy, cross-over trial to assess the bronchodilation effect of a single dose of LAS40468 and a single dose of salmeterol/fluticasone propionate (Seretide®) administered to adult patients with stable asthma.

The study will consist of a screening visit and treatment periods of approximately 13 hours separated by washout periods of 7 to 14 days from the time of Investigational Medicinal product (IMP) administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Adult males and non-pregnant, non-lactating females aged between 18 and 60 years (both inclusive)

• Patients with a confirmed 6-months' history of asthma at the time of enrolment into the trial

• Patients treated with short-acting beta-agonists or inhaled corticosteroids at a stable dose and regimen (up to the equivalent of 1600 µg/day of beclometasone dipropionate) for at least 4 weeks prior to screening

• Patients whose (pre-salbutamol) forced expiratory volume in 1 second (FEV1) at screening is >60% of the predicted normal value after a washout of at least 6 hours for short-acting beta-agonists and 48 hours for long-acting beta-agonists, if applicable

• Patients with a FEV1 absolute increase of at least 250 mL over baseline value after inhalation of 4 puffs of 100 µg of salbutamol in one of two pulmonary function tests performed within 10-15 min

Exclusion Criteria:

• Patients with clinically significant respiratory or pulmonary diseases other than asthma or history of thoracic surgery

• Patients with a Body Mass Index (BMI) < 18 or > 40kg/m2 (both inclusive)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• LAS40468

• Salmeterol/fluticasone propionate

• Placebo

Locations

Country	Name	City	State
Germany	Almirall Investigational Site #1	Berlin
United Kingdom	Almirall Investigational Site #2	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
Almirall, S.A.

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline (pre-dose at each period) in normalised forced expiratory volume in 1 second (FEV1) area under the curve (AUC) over the 12 hour period after IMP administration (AUC0-12)		12 Hours	No
Secondary	Adverse events	An adverse event (AE) is any untoward medical occurrence in a clinical trial subject (regardless of the administration of the IMP and the causal relationship to it). An AE can therefore be any unfavourable and unintended medical occurrence during subject's participation in the trial, including deterioration of a pre-existing medical, an ECG abnormality, a blood pressure abnormal value or an abnormal finding in the physical examination.; A Serious AE is any AE that: results in death, is life-threatening, requires hospitalisation or prolongs existing hospitalisation, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is any other medically important event that may jeopardise the subject or may require intervention to prevent one of the other above outcomes. Any suspected transmission via a medicinal product of an infectious agent is also considered a serious AE.	7-9 weeks	Yes